IRT Project Manager

The IRT Project Manager is accountable for the client's study specific Interactive Response Technology (IRT) implementation, ongoing conduct support, closeout and decommission.

Summary of Responsibilities:

• Lead study-specific IRT Implementation Teams, coordinating cross-functional stakeholders including Clinical Trial Supply, Global Clinical Operations, Biostatistics, Data Management, and vendors.
• Create and manage IRT-related timelines and deliverables.
• Conduct internal review meetings for vendor-written specifications and integration documents.
• Plan, facilitate, and lead IRT study review meetings.
• Ensure completion and approval of all IRT documentation, including specifications.
• Serve as the primary point of contact for the IRT vendor for study-specific matters.
• Ensure compliance with relevant regulations such as GxPs and ICH E6.
• Provide guidance to the IRT Implementation Team on optimal system utilization.
• Act as a subject matter expert on IRT best practices and share lessons learned across teams.
• Define and complete initial documentation for scope of work requests from vendors.
• Review and provide expert input on User Requirement Specifications and other IRT-related documents.
• Review and approve UAT schedules aligned with URS.
• Create study-specific IRT Test Plans and test scripts.
• Facilitate UAT execution, coordinate issue resolution with vendors, and ensure proper documentation.
• Define and oversee data exchange requirements between IRT and other systems.
• Collaborate with stakeholders to determine integration solutions.
• Manage initial and ongoing testing to ensure efficient and error-free data transfers.
• Guide study teams on site-initiated data changes and vendor implementation.
• Facilitate collection of closeout deliverables from IRT vendors.
• Maintain a study-specific issue and risk log, documenting root causes, corrective actions, and preventive measures.
• Advise on system changes post-launch to ensure alignment with study and program needs.
• Manage study-specific IRT contracts, budgets, and change orders.
• Support the Global IRT Lead in process governance and standardization.
• Maintain consistency in IRT terminology, functionality, and reporting across studies.
• Assist in metrics collection and reporting.
• Recommend improvements to quality procedures and best practices.
• Conduct or develop IRT-related training for internal teams.
• Foster collaboration across internal stakeholders including Clinical Trial Supplies, eClinical Technology, Global Clinical Operations, Biostatistics, Data Management, Clinical Quality, Regulatory, and Outsourcing.
• Provide regular updates to the Line Manager and escalate issues as needed.
• Perform all other duties as needed or assigned.

Qualifications (Minimum Required):

• University / college degree (life sciences, health sciences, information technology or related subjects preferred) or a certification in allied health professions from an appropriate accredited institution.
• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Fluent in English, both written and verbal.

Experience (Minimum Required):

• 5–6 years of relevant experience in clinical systems project management, with a strong focus on or IRT and/or eCOA platforms
• Hands-on experience in User Acceptance Testing (UAT), including planning, execution, defect tracking, and system go-live support.
• Proven ability to manage outsourced technology vendors and collaborate with sponsors and cross-functional teams.
• Strong problem-solving skills with a proactive and detail-oriented approach to issue resolution and system validation.
• Effective oral and written communication skills for stakeholder engagement, documentation, and reporting.
• Solid understanding of the clinical trial lifecycle, including system implementation, data flow, regulatory compliance, and TMF documentation.
• Ability to work independently and collaboratively in a fast-paced, team-oriented environment with minimal supervision.
• Strong time management and prioritization skills, with the ability to meet tight deadlines while maintaining high-quality standards.
• Demonstrated self-motivation, accountability, and ownership of assigned tasks.
• A cooperative and team-oriented mindset, with a willingness to support peers and contribute to shared goals.

Pay Range: $110,000-$125,000

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.